Breast CancerPhase 2NCT00431795
Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer
A Phase 2 study testing Pegylated liposomal doxorubicin (Caelyx) and Epirubicin in people with Breast Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
Trial summary
DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pegylated liposomal doxorubicin (Caelyx) and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesGreece
- Study dates
- Jun 2003to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
- Histologically- or cytologically- confirmed breast adenocarcinoma
- No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
- No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
Show all 10Show fewer
- At least 4 weeks interval since prior anticancer treatment
- Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
- Life expectancy > 3 months
- Written informed consent
Who cannot join
- Pregnancy or nursing
- Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
- Other invasive malignancy except nonmelanoma skin cancer or acute infection.
- Radiation of measurable disease (except brain metastases)
- Progressive brain metastases according to clinical or radiological criteria.
- Brain metastases without prior radiation therapy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Greece10 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens
401 Military Hospital of Athens
Athens
Air Forces Military Hospital of Athens
Athens
University Hospital of Crete
Heraklion, Crete, 71110
State General Hospital of Larissa, Dep of Medical Oncology
Larissa
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
About this study
Official title: A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients
DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy
Read the detailed description
To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer
- Conditions
- Breast Cancer
- Being tested
- Pegylated liposomal doxorubicin (Caelyx), Epirubicin
- Keywords
- Advanced breast cancer, Pegylated liposomal doxorubicin, Epirubicin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated liposomal doxorubicin (Caelyx)Drug
Also called Caelyx
Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles
EpirubicinDrug
Also called Farmorubicine
Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Epi Receives: Drug: Epirubicin |
| 2 | Experimental | Cael Receives: Drug: Pegylated liposomal doxorubicin (Caelyx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of antitumor efficacy by objective tumor response rates
Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
Secondary outcomes (3)
Toxicity profile and tolerance between the two treatment arms
Measured: Toxicity assessment of each chemotherapy cycle
Time to progression
Measured: 1 year
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startJun 2003
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Responsible party
- Sponsor
- Investigators
- Dimitris Mavrudis, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431795
- Sponsor's protocol ID
- CT/03.12
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2007
- Last updated
- 13 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00431795
- Acronym / sponsor ID
- CT/03.12
- Conditions
- Breast Cancer
- Keywords
- Advanced breast cancer, Pegylated liposomal doxorubicin, Epirubicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor accrual
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Jun 2003
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy
Detailed description
To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EpirubicinEpi |
| 2 | Experimental | Drug: Pegylated liposomal doxorubicin (Caelyx)Cael |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
- Histologically- or cytologically- confirmed breast adenocarcinoma
- No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
Key exclusion criteria (6 listed)
- Pregnancy or nursing
- Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
- Other invasive malignancy except nonmelanoma skin cancer or acute infection.
- Radiation of measurable disease (except brain metastases)
- Progressive brain metastases according to clinical or radiological criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated liposomal doxorubicin (Caelyx)Also: CaelyxPegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles | Drug | 2 |
| EpirubicinAlso: FarmorubicineEpirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles | Drug | 1 |
Primary outcome
Assessment of antitumor efficacy by objective tumor response rates
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
3 secondary outcomes
Toxicity profile and tolerance between the two treatment arms
Time frame: Toxicity assessment of each chemotherapy cycle
Time to progression
Time frame: 1 year
Overall survival
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Due to poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitris Mavrudis, MD principal investigator
University Hospital of Crete
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated liposomal doxorubicin (Caelyx) and Epirubicin in people with Breast Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of antitumor efficacy by objective tumor response rates (time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.